CN102770157B - 抗体的配制品 - Google Patents

抗体的配制品 Download PDF

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Publication number
CN102770157B
CN102770157B CN201080060508.0A CN201080060508A CN102770157B CN 102770157 B CN102770157 B CN 102770157B CN 201080060508 A CN201080060508 A CN 201080060508A CN 102770157 B CN102770157 B CN 102770157B
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CN
China
Prior art keywords
preparation
histidine
under
trehalose
phosphate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN201080060508.0A
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English (en)
Chinese (zh)
Other versions
CN102770157A (zh
Inventor
卡尔蒂克·拉马尼
苏查里塔·亚卡尔
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Centro de Immunologia Molecular
Biocon Ltd
Original Assignee
Centro de Immunologia Molecular
Biocon Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
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Publication of CN102770157A publication Critical patent/CN102770157A/zh
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CN201080060508.0A 2009-11-20 2010-11-19 抗体的配制品 Active CN102770157B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN2859CH2009 2009-11-20
IN2859/CHE/2009 2009-11-20
PCT/IB2010/055296 WO2011061712A1 (en) 2009-11-20 2010-11-19 Formulations of antibody

Publications (2)

Publication Number Publication Date
CN102770157A CN102770157A (zh) 2012-11-07
CN102770157B true CN102770157B (zh) 2017-05-17

Family

ID=44059267

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201080060508.0A Active CN102770157B (zh) 2009-11-20 2010-11-19 抗体的配制品

Country Status (20)

Country Link
US (4) US20120231009A1 (nl)
EP (2) EP2501408B1 (nl)
JP (2) JP5896471B2 (nl)
KR (1) KR101333276B1 (nl)
CN (1) CN102770157B (nl)
AU (1) AU2010320515B2 (nl)
BR (1) BR112012012080B1 (nl)
CA (1) CA2781467C (nl)
CU (1) CU20120080A7 (nl)
DK (1) DK3721904T3 (nl)
ES (1) ES2897500T3 (nl)
IL (1) IL219884A (nl)
MX (1) MX2012005863A (nl)
MY (1) MY165614A (nl)
NZ (1) NZ600096A (nl)
PL (1) PL3721904T3 (nl)
PT (1) PT3721904T (nl)
RU (1) RU2548772C2 (nl)
WO (1) WO2011061712A1 (nl)
ZA (1) ZA201204459B (nl)

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US20140186361A1 (en) 2012-09-07 2014-07-03 Coherus Biosciences, Inc. Stable Aqueous Formulations of Adalimumab
JOP20080381B1 (ar) 2007-08-23 2023-03-28 Amgen Inc بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9)
CA2716919C (en) 2008-03-14 2015-01-20 Biocon Limited An anti-cd6 monoclonal antibody and use thereof
US20130064834A1 (en) 2008-12-15 2013-03-14 Regeneron Pharmaceuticals, Inc. Methods for treating hypercholesterolemia using antibodies to pcsk9
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
RS57339B1 (sr) 2011-01-28 2018-08-31 Sanofi Biotechnology Ljudska antitela za pcsk9 za primenu u postupcima tretiranja posebnih grupa pacijenata
AR087305A1 (es) 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
CA2848201C (en) 2011-09-16 2020-10-27 Regeneron Pharmaceuticals, Inc. Methods for reducing lipoprotein(a) levels by administering an inhibitor of proprotein convertase subtilisin kexin-9 (pcsk9)
NZ627859A (en) 2012-01-23 2015-09-25 Regeneron Pharma Stabilized formulations containing anti-ang2 antibodies
AR092325A1 (es) 2012-05-31 2015-04-15 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-dll4 y kit
CN102961745B (zh) * 2012-09-27 2015-02-18 苏州康聚生物科技有限公司 抗体组合物制剂及其应用
PL2916866T3 (pl) 2012-11-06 2018-10-31 Bayer Pharma Aktiengesellschaft Formulacja dwuswoistych przeciwciał mobilizujących limfocyty t (bite)
US10111953B2 (en) 2013-05-30 2018-10-30 Regeneron Pharmaceuticals, Inc. Methods for reducing remnant cholesterol and other lipoprotein fractions by administering an inhibitor of proprotein convertase subtilisin kexin-9 (PCSK9)
EP3024485B1 (en) 2013-07-23 2020-11-18 Biocon Limited Use of a cd6 binding partner and method based thereon
SI3043776T1 (sl) 2013-09-11 2024-03-29 Eagle Biologics, Inc. Tekoče proteinske formulacije, ki vsebujejo vodotopna organska barvila
US10428157B2 (en) 2013-11-12 2019-10-01 Sanofi Biotechnology Dosing regimens for use with PCSK9 inhibitors
WO2015181757A1 (en) * 2014-05-28 2015-12-03 Nono Inc. Lyophilized formulation of tat-nr2b9c with acetylation scavenger
US10544232B2 (en) 2014-07-16 2020-01-28 Sanofi Biotechnology Methods for treating patients with heterozygous familial hypercholesterolemia (heFH) with an anti-PCSK9 antibody
EP3200804A4 (en) 2014-10-01 2018-04-18 Eagle Biologics, Inc. Polysaccharide and nucleic acid formulations containing viscosity-lowering agents
CN104922668B (zh) * 2014-12-10 2019-08-23 信达生物制药(苏州)有限公司 一种稳定的抗vegf抗体制剂及其用途
KR101776879B1 (ko) 2015-01-19 2017-09-08 주식회사 녹십자 항-egfr 항체를 포함하는 약학 제제
CN107922507B (zh) 2015-08-18 2022-04-05 瑞泽恩制药公司 抗pcsk9抑制性抗体用来治疗接受脂蛋白单采的高脂血症患者
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
US11071782B2 (en) 2016-04-20 2021-07-27 Coherus Biosciences, Inc. Method of filling a container with no headspace
CN109862880A (zh) * 2016-09-27 2019-06-07 德国费森尤斯卡比有限公司 液体药物组合物
KR102514528B1 (ko) 2016-10-21 2023-03-27 바이오콘 리미티드 루푸스 치료를 위한 단일클론항체 및 이의 치료방법
CN106800598B (zh) * 2017-02-09 2020-08-07 广州桂雨生物科技有限公司 一种抗体保存液及其制备方法
CN111110841A (zh) * 2018-10-31 2020-05-08 上海君实生物医药科技股份有限公司 含有抗pcsk9抗体的稳定制剂
BR112021015034A2 (pt) 2019-02-18 2021-10-05 Eli Lilly And Company Formulação de anticorpo terapêutico
CN113116812A (zh) * 2019-12-30 2021-07-16 百奥泰生物制药股份有限公司 含抗Trop2抗体-药物偶联物的制剂及其制备方法和应用
US11498626B2 (en) 2020-11-11 2022-11-15 Rivian Ip Holdings, Llc Vehicle tailgate assembly
CN113289027B (zh) * 2021-05-18 2022-07-01 中国兽医药品监察所 一种通用型单克隆抗体耐热保护剂
WO2024083074A1 (en) * 2022-10-17 2024-04-25 Beigene, Ltd. Formulations containing anti-tigit antibody and methods of use thereof

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CN101199483A (zh) * 2006-12-14 2008-06-18 上海中健生物技术研究院 一种稳定的抗her2人源化抗体制剂

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CN101199483A (zh) * 2006-12-14 2008-06-18 上海中健生物技术研究院 一种稳定的抗her2人源化抗体制剂

Also Published As

Publication number Publication date
PT3721904T (pt) 2021-11-15
JP5896471B2 (ja) 2016-03-30
JP2016104780A (ja) 2016-06-09
BR112012012080B1 (pt) 2022-11-29
KR20130028894A (ko) 2013-03-20
DK3721904T3 (da) 2021-11-15
ES2897500T8 (es) 2022-03-10
ZA201204459B (en) 2013-02-27
KR101333276B1 (ko) 2013-11-27
EP3721904B1 (en) 2021-10-13
AU2010320515A1 (en) 2012-06-14
JP2013511510A (ja) 2013-04-04
PL3721904T3 (pl) 2022-01-31
US20210290525A1 (en) 2021-09-23
IL219884A (en) 2015-11-30
BR112012012080A2 (nl) 2021-11-03
CA2781467C (en) 2015-10-13
RU2012125254A (ru) 2013-12-27
RU2548772C2 (ru) 2015-04-20
EP2501408A4 (en) 2014-10-08
US20240058263A1 (en) 2024-02-22
CN102770157A (zh) 2012-11-07
ES2897500T3 (es) 2022-03-01
CU20120080A7 (es) 2012-10-15
EP2501408A1 (en) 2012-09-26
MY165614A (en) 2018-04-18
US20190321285A1 (en) 2019-10-24
EP2501408B1 (en) 2020-05-27
MX2012005863A (es) 2013-01-18
US20120231009A1 (en) 2012-09-13
EP3721904A1 (en) 2020-10-14
WO2011061712A1 (en) 2011-05-26
IL219884A0 (en) 2012-07-31
AU2010320515B2 (en) 2013-05-02
CA2781467A1 (en) 2011-05-26
NZ600096A (en) 2013-08-30

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